Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
Sponsor study identifier
interventional
247
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
December 2017
Actual (reported)PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 21, 2012
Actual (reported)January 1, 2013
Actual (reported)June 2016
Actual (reported)December 2017
Actual (reported)Olerud-Molander score
Ankle functional outcome measure
1 year
FAOS
1 year
VAS
1 year
RAND 36 Health item survey
1 year
Fracture healing
1 year
Removable ankle brace/splint
Below-the-knee cast (glass fiber)
Below-the-knee cast (glass fiber)
A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.
A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.
OYS, kirurgian klinkka, Oulu
Oulu, 90100, Finland
Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.
Harri J Pakarinen, MD, PhD
Oulu University Hospital
Tero HJ Kortekangas, MD
Oulu University Hospital
247 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2012
First Posted
January 1, 2013
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.
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Primary Completion
June 2016
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
October 18, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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